Teldra

Teldra

telmisartan

Manufacturer:

Hebei Tiancheng

Distributor:

Bell-Kenz Pharma

Marketer:

AMB HK
Concise Prescribing Info
Contents
Telmisartan
Indications/Uses
Essential HTN in adults. Reduction of CV morbidity in adults w/ manifest atherothrombotic CV disease (history of CHD, stroke, or peripheral arterial disease) or type 2 DM w/ documented target organ damage.
Dosage/Direction for Use
Essential HTN 40 mg once daily, can be increased to a max of 80 mg once daily if target BP is not achieved. CV prevention 80 mg once daily. Patient w/ renal impairment Lower starting dose of 20 mg is recommended. Patient w/ mild to moderate hepatic impairment Should not exceed 40 mg once daily.
Administration
May be taken with or without food.
Contraindications
Hypersensitivity. Biliary obstructive disorders. Severe hepatic impairment. Concomitant use w/ aliskiren-containing products in patients w/ DM or renal impairment (GFR <60 mL/min/1.73 m2). Pregnancy (2nd & 3rd trimesters).
Special Precautions
Increased risk of severe hypotension & renal insufficiency in patients w/ bilateral renal artery stenosis or stenosis of the artery to a single functioning kidney. Not to be given to patients w/ cholestasis, biliary obstructive disorders or severe hepatic impairment. Symptomatic hypotension, especially after the 1st dose, may occur in patients who are vol &/or Na depleted by vigorous diuretic therapy, dietary salts restriction, diarrhoea, or vomiting. Dual blockade of the renin-angiotensin-aldosterone-system (RAAS) is not recommended. Associated w/ acute hypotension, hyperazotaemia, oliguria, or rarely acute renal failure in patients whose vascular tone & renal function depend predominantly on the activity of RAAS (eg, patients w/ severe CHF or underlying renal disease, including renal artery stenosis). Not recommended for use in patients w/ primary aldosteronism. Risk of hypoglycaemia in diabetic patients treated w/ insulin or antidiabetics. May cause hyperkalemia. Excessive BP reduction in patients w/ ischaemic cardiopathy or ischaemic CV disease could result in MI or stroke. Should not be taken by patients w/ fructose intolerance. Less effective in lowering BP in black people. Periodically monitor K & creatinine serum levels in patients w/ impaired renal function. Caution in patients suffering from aortic or mitral stenosis, or obstructive hypertrophic cardiomyopathy; patients w/ mild to moderate hepatic impairment. Not recommended during pregnancy (1st trimester) & lactation. Safety & efficacy have not been established in childn & adolescents <18 yr.
Adverse Reactions
UTI including cystitis, URTI including pharyngitis & sinusitis; anaemia; hyperkalaemia; insomnia, depression; syncope; vertigo; bradycardia; hypotension, orthostatic hypotension; dyspnoea, cough; abdominal pain, diarrhoea, dyspepsia, flatulence, vomiting; pruritus, hyperhidrosis, rash; back pain (eg, sciatica), muscle spasms, myalgia; renal impairment including acute renal failure; chest pain, asthenia (weakness); increased blood creatinine.
Drug Interactions
Increase in digoxin peak plasma conc & trough conc. Increased risk of hyperkalemia w/ salt substitutes containing K, K-sparing diuretics (eg, spironolactone, eplerenone, triamterene, or amiloride), K supplements, ACE inhibitors, angiotensin II receptor antagonists, NSAIDs (including selective COX-2 inhibitors), heparin, immunosuppressives (cyclosporin or tacrolimus), & trimethoprim. Reversible increases in serum lithium conc & toxicity. NSAIDs (ie, ASA at anti-inflammatory dosage regimens, COX-2 inhibitors & non-selective NSAIDs) may reduce antihypertensive effect of the treatment. Co-administration w/ COX inhibitors in patients w/ compromised renal function may result in further deterioration of renal function, including possible acute renal failure, which is usually reversible. Vol depletion & risk of hypotension w/ high dose diuretics eg, furosemide (loop diuretic) & hydrochlorothiazide (thiazide diuretic). Increased BP lowering effect w/ other antihypertensive agents. Higher frequency of adverse events w/ combined use of ACE inhibitors, ARBs or aliskiren. May potentiate hypotensive effects w/ baclofen & amifostine. May aggravate orthostatic hypotension w/ alcohol, barbiturates, narcotics, or antidepressants. Reduced antihypertensive effect w/ corticosteroids (systemic route).
MIMS Class
Angiotensin II Antagonists
ATC Classification
C09CA07 - telmisartan ; Belongs to the class of angiotensin II receptor blockers (ARBs). Used in the treatment of cardiovascular disease.
Presentation/Packing
Form
Teldra tab 40 mg
Packing/Price
30's (P14/tab, P420/box)
Form
Teldra tab 80 mg
Packing/Price
30's (P19.5/tab, P585/box)